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bicarbonates
bicarbonates is a Small molecule drug developed by University Hospital, Caen. It is currently in Phase 3 development.
Bicarbonate is a polyatomic anion with the chemical formula HCO−3, formed through the deprotonation of carbonic acid. Bicarbonate has been studied in clinical trials for various conditions, including severe rotavirus gastroenteritis, renal failure, and gastric acid regulation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | bicarbonates |
|---|---|
| Sponsor | University Hospital, Caen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS
- SODium BICarbonate for Metabolic Acidosis in the ICU (PHASE3)
- Bladder Directed vs. Pelvic Floor Therapy in IC/BPS (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis (PHASE3)
- Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation (NA)
- Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia
- Oropharyngeal Care With Colostrum, Chlorohexidine and Sodium Bicarbonate in Preventing Ventilator-associated Pneumonia in Preterm Neonates (NA)
- Prevention of Oral Mucositis in Head and Neck Cancer. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- bicarbonates CI brief — competitive landscape report
- bicarbonates updates RSS · CI watch RSS
- University Hospital, Caen portfolio CI
Frequently asked questions about bicarbonates
What is bicarbonates?
Who makes bicarbonates?
What development phase is bicarbonates in?
Related
- Manufacturer: University Hospital, Caen — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing